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Mr. Fleder provided a very interesting and well-written analysis of the limited numbers of cases that review and interpret the FDCA statutory basis for FDA inspections and other related statutory frameworks. For practitioners of Food and Drug law, it is a great article and something to consider as situations present themselves. However, this is NOT something that should be considered by those with operational responsibilities for inspection management, IMO. At best, forward these articles to your in-house or outside regulatory attorney with an “FYI, interesting” and leave it at that. The article presents a “what if” question of law only.

Practically, unless you are directed with good cause from your in-house regulatory attorney, or competent outside counsel, to question an FDA form 482 and FDA’s inspectional authority, it is strongly recommended that you accept that authority and permit access to your regulated facility. As Mr. Fleder himself said in the beginning of the article:

“there is at least one subject that seems to generate universal agreement: FDA has the authority to issue a Form 482 to a companies [sic] subject to inspection under 21 U.S.C. § 374, and those companies have no right to refuse FDA’s entry to a facility.”

Failure to permit or unreasonably restrict access when presented with valid credentials and a Form 482 can result in a Notice of Refusal — and, although that is the subject of another discussion — that is something that you don’t want to be presented with.